Prostate CancerNCT02858128
WB-DW-MRI vs CHOLINE-PET/CT for Selecting Treatments in Recurrent Prostate Cancer
An observational study of Prostate Cancer, run by Hospital Provincial de Castellon.
Trial summary
The purpose of this study is to determine the effectiveness of whole-body diffusion-weighted magnetic resonance imaging (WB-DW- MRI) in detecting metastases by comparing the results with those from choline-positron emission tomography-computed tomography (choline-PET/CT) in patients with metastatic/oligometastatic… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- IMAGING STUDY
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Mar 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: 46 consecutive patients given a diagnosis of prostate cancer by the Radiation Oncology Department of our center, between October 2014 and March 2015 who met the established inclusion criteria: a histological diagnosis of prostate cancer, and after treatment of the primary disease, a diagnosis of biochemical relapse and no metastases or oligometastatic stage (less than 5 lesions) in conventional diagnostic images (bone scintigraphy, chest-abdominal and pelvic CT and pelvic MRI).
Who may be able to join
- Prostate cancer histologic diagnostic after one treatment
- 5 o less lessions
- Asimptomatic lessions
- Informed Consent Form signed
Who cannot join
- Not capability to perform NMR os CT/PET scans
About this study
Official title: WHOLE-BODY DIFFUSION-WEIGHTED MAGNETIC RESONANCE IMAGING (WB-DW-MRI) VS CHOLINE-POSITRON EMISSION TOMOGRAPHY-COMPUTED TOMOGRAPHY (CHOLINE- PET/CT) for Selecting Treatments in Recurrent Prostate Cancer
The purpose of this study is to determine the effectiveness of whole-body diffusion-weighted magnetic resonance imaging (WB-DW- MRI) in detecting metastases by comparing the results with those from choline-positron emission tomography-computed tomography (choline-PET/CT) in patients with metastatic/oligometastatic prostate cancer. Patients with this disease profile who could benefit from treatment with stereotactic body radiation therapy (SBRT) were selected and their responses to these techniques were rated.
Read the detailed description
This was a prospective, controlled, unicentric study, involving 46 consecutive patients from our centre who presented biochemical relapse after adjuvant, salvage or radical treatment with external beam radiotherapy, or brachytherapy. After initial tests ( bone scintigraphy, CT, pelvic MRI) 35 patients with oligometastases or without them were selected. 11 patients with multiple metastases were excluded from the study. WB-DW- MRI and choline-PET/CT was then performed on each patient within one week. The results were interpreted by specialists in nuclear medicine and MRI. If they were candidates for treatment with ablative SBRT (SABR) they were then evaluated every three months with both tests.
- Conditions
- Prostate Cancer
- Being tested
- IMAGING STUDY
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMAGING STUDYOther
Choline-PET/CT versus NMRscan comparative study
What is being measured
The primary outcome is the main question the study is designed to answer.
effectiveness of whole-body diffusion-weighted magnetic resonance imaging (WB-DW- MRI) in detecting metastases
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2016 (estimated)
- Study startOct 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Provincial de Castellon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio J Conde Moreno, Hospital Provincial de Castellon
- Investigators
- Antonio J Conde Moreno, MD PhD, Principal investigator, Hospital Provincial de Castellon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02858128
- Sponsor's protocol ID
- PRV00024
- Status last verified
- Aug 2016
- First submitted
- 3 Aug 2016
- Last updated
- 9 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Conde-Moreno AJ, Herrando-Parreno G, Muelas-Soria R, Ferrer-Rebolleda J, Broseta-Torres R, Cozar-Santiago MP, Garcia-Pinon F, Ferrer-Albiach C. Whole-body diffusion-weighted magnetic resonance imaging (WB-DW-MRI) vs choline-positron emission tomography-computed tomography (choline-PET/CT) for selecting treatments in recurrent prostate cancer. Clin Transl Oncol. 2017 May;19(5):553-561. doi: 10.1007/s12094-016-1563-4. Epub 2016 Oct 31.
PubMed 27796820
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WHOLE-BODY DIFFUSION-WEIGHTED MAGNETIC RESONANCE IMAGING (WB-DW-MRI) VS CHOLINE-POSITRON EMISSION TOMOGRAPHY-COMPUTED TOMOGRAPHY (CHOLINE- PET/CT) for Selecting Treatments in Recurrent Prostate Cancer
- ClinicalTrials.gov ID
- NCT02858128
- Acronym / sponsor ID
- PRV00024
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Hospital Provincial de CastellonUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 8 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effectiveness of whole-body diffusion-weighted magnetic resonance imaging (WB-DW- MRI) in detecting metastases by comparing the results with those from choline-positron emission tomography-computed tomography (choline-PET/CT) in patients with metastatic/oligometastatic prostate cancer. Patients with this disease profile who could benefit from treatment with stereotactic body radiation therapy (SBRT) were selected and their responses to these techniques were rated.
Detailed description
This was a prospective, controlled, unicentric study, involving 46 consecutive patients from our centre who presented biochemical relapse after adjuvant, salvage or radical treatment with external beam radiotherapy, or brachytherapy. After initial tests ( bone scintigraphy, CT, pelvic MRI) 35 patients with oligometastases or without them were selected. 11 patients with multiple metastases were excluded from the study. WB-DW- MRI and choline-PET/CT was then performed on each patient within one week. The results were interpreted by specialists in nuclear medicine and MRI. If they were candidates for treatment with ablative SBRT (SABR) they were then evaluated every three months with both tests.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 46 consecutive patients given a diagnosis of prostate cancer by the Radiation Oncology Department of our center, between October 2014 and March 2015 who met the established inclusion criteria: a histological diagnosis of prostate cancer, and after treatment of the primary disease, a diagnosis of biochemical relapse and no metastases or oligometastatic stage (less than 5 lesions) in conventional diagnostic images (bone scintigraphy, chest-abdominal and pelvic CT and pelvic MRI).
Key inclusion criteria (4 listed)
- Prostate cancer histologic diagnostic after one treatment
- 5 o less lessions
- Asimptomatic lessions
- Informed Consent Form signed
Key exclusion criteria (1 listed)
- Not capability to perform NMR os CT/PET scans
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMAGING STUDYCholine-PET/CT versus NMRscan comparative study | Other | – |
Primary outcome
effectiveness of whole-body diffusion-weighted magnetic resonance imaging (WB-DW- MRI) in detecting metastases
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2016.
- Derived from this study: PubMed 27796820Conde-Moreno AJ, Herrando-Parreno G, Muelas-Soria R, Ferrer-Rebolleda J, Broseta-Torres R, Cozar-Santiago MP, Garcia-Pinon F, Ferrer-Albiach C. Whole-body diffusion-weighted magnetic resonance imaging (WB-DW-MRI) vs choline-positron emission tomography-computed tomography (choline-PET/CT) for selecting treatments in recurrent prostate cancer. Clin Transl Oncol. 2017 May;19(5):553-561. doi: 10.1007/s12094-016-1563-4. Epub 2016 Oct 31.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio J Conde Moreno, MD PhD principal investigator
Hospital Provincial de Castellon
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Hospital Provincial de Castellon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effectiveness of whole-body diffusion-weighted magnetic resonance imaging (WB-DW- MRI) in detecting metastases (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02858128, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2016.